Status:
RECRUITING
Regulating Blood Pressure During Recovery From Intracerebral Hemorrhage and Ischemic Stroke
Lead Sponsor:
Yale University
Collaborating Sponsors:
American Heart Association
Conditions:
Intracerebral Hemorrhage
Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this research study is to determine whether blood pressure treatment regimens with spironolactone are better than blood pressure treatment regimens without spironolactone at lowering bl...
Detailed Description
This is a pragmatic, randomized, open-label, blinded-endpoint trial comparing spironolactone-containing antihypertensive regimens versus standard antihypertensive regimens based on the 2017 AHA/ACC gu...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Symptomatic ICH confirmed by head CT or brain MRI during hospitalization OR ischemic stroke patients. Ischemic stroke will be defined by focal signs/symptoms of any duration associated with evidence of acute arterial infarction on neuroimaging or clinical evidence of cerebral focal arterial ischemic injury with symptoms persisting ≥ 24 hours.
- Written, informed consent by patient or surrogate
- Ability to comply with all study procedures and available for the duration of the study
Exclusion
- Secondary ICH due to trauma, vascular malformation, or tumor
- Life expectancy \< 1 year
- eGFR \<45
- Serum potassium greater than or equal to the upper limit of normal of the lab on the two most recent consecutive potassium levels prior to enrollment
- Known hypersensitivity to spironolactone
- Upper arm greater than 17 inches in circumference
- Pregnancy, planned pregnancy, or breastfeeding
- Contraindication to discontinuing mineralocorticoid antagonist therapy for 3-12 months per the investigator's discretion (e.g., refractory proteinuria)
- Systolic BP \>200 mmHg or diastolic BP \>110 mmHg at the time of randomization
- Systolic BP \<120 mmHg at the time of randomization
- Any condition which, in the judgement of the investigator, increases the risk to the patient
- History of Addison's disease
Key Trial Info
Start Date :
March 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04760717
Start Date
March 19 2021
End Date
December 1 2025
Last Update
April 11 2025
Active Locations (5)
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1
Yale New Haven Hospital
New Haven, Connecticut, United States, 06512
2
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27157
3
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
4
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140